Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002547
Status:
COMPLETED
Last Update Posted:
2012-08-07
First Post:
1999-11-01
Brief Title:
Chemotherapy and Bone Marrow Transplantation in Treating Patients Acute Myeloid With Leukemia or Myelodysplastic Syndrome
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
ALLOGENEIC AND SYNGENEIC MARROW TRANSPLANTATION IN PATIENTS WITH ACUTE NON-LYMPHOCYTIC LEUKEMIA
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy and kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of bone marrow transplantation following combination chemotherapy in treating patients with acute myeloid leukemia or myelodysplastic syndrome
PURPOSE Phase II trial to study the effectiveness of bone marrow transplantation following combination chemotherapy in treating patients with acute myeloid leukemia or myelodysplastic syndrome
Detailed Description:
OBJECTIVES I Determine overall and leukemia-free survival of patients with acute nonlymphocytic leukemia or myelodysplastic syndrome treated with busulfan and cyclophosphamide low-risk patients or cytarabine busulfan and cyclophosphamide high-risk patients followed by allogeneic or syngeneic bone marrow transplantation II Compare the therapeutic effects of these cytoreduction regimens with those reported in the literature for similar patients who undergo syngeneic or allogeneic marrow transplantation following cytoreduction that includes total-body irradiation III Determine the early and late toxic effects produced by these chemotherapy regimens in this patient population
OUTLINE Low-risk patients those in first complete remission CR who achieved CR with 1 course of chemotherapy are treated on Regimen A High-risk patients those in second or subsequent CR who required more than 1 course of chemotherapy to achieve first CR or those with myelodysplastic syndrome are treated on Regimen B All patients undergo diagnostic lumbar puncture prior to beginning therapy and fluid is examined for CNS disease Patients receive methotrexate IT along with the tap Prior to initiation of chemotherapy patients with CNS disease present on diagnostic lumbar puncture receive methotrexate IT every 2-3 days until lumbar puncture shows no leukemia cells and then 1 additional dose Cytoreductive chemotherapy begins 3 days after the last dose of methotrexate Regimen A Patients receive oral busulfan every 6 hours on days -7 to -4 for a total of 16 doses and cyclophosphamide IV over 2 hours on days -3 and -2 Allogeneic bone marrow is infused on day 0 Regimen B Patients receive oral busulfan every 6 hours on days -9 to -6 for a total of 16 doses Patients receive cytarabine IV over 1 hour every 12 hours on days -5 and -4 and cyclophosphamide IV over 2 hours on days -3 and -2 Allogeneic bone marrow is infused on day 0 Graft versus host disease prophylaxis Patients receive cyclosporine IV continuously on days -1 to 28 followed by a taper of oral cyclosporine until day 180 Patients receive methotrexate IV on days 1 3 6 and 11 CNS disease prophylaxis Patients receive 5 more doses of methotrexate IT weekly beginning between days 50 and 70 In addition patients with history of CNS disease receive 1 dose of methotrexate IT monthly for 1 year Patients are followed frequently during the first 100 days at 6 months 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 27 years
OUTLINE Low-risk patients those in first complete remission CR who achieved CR with 1 course of chemotherapy are treated on Regimen A High-risk patients those in second or subsequent CR who required more than 1 course of chemotherapy to achieve first CR or those with myelodysplastic syndrome are treated on Regimen B All patients undergo diagnostic lumbar puncture prior to beginning therapy and fluid is examined for CNS disease Patients receive methotrexate IT along with the tap Prior to initiation of chemotherapy patients with CNS disease present on diagnostic lumbar puncture receive methotrexate IT every 2-3 days until lumbar puncture shows no leukemia cells and then 1 additional dose Cytoreductive chemotherapy begins 3 days after the last dose of methotrexate Regimen A Patients receive oral busulfan every 6 hours on days -7 to -4 for a total of 16 doses and cyclophosphamide IV over 2 hours on days -3 and -2 Allogeneic bone marrow is infused on day 0 Regimen B Patients receive oral busulfan every 6 hours on days -9 to -6 for a total of 16 doses Patients receive cytarabine IV over 1 hour every 12 hours on days -5 and -4 and cyclophosphamide IV over 2 hours on days -3 and -2 Allogeneic bone marrow is infused on day 0 Graft versus host disease prophylaxis Patients receive cyclosporine IV continuously on days -1 to 28 followed by a taper of oral cyclosporine until day 180 Patients receive methotrexate IV on days 1 3 6 and 11 CNS disease prophylaxis Patients receive 5 more doses of methotrexate IT weekly beginning between days 50 and 70 In addition patients with history of CNS disease receive 1 dose of methotrexate IT monthly for 1 year Patients are followed frequently during the first 100 days at 6 months 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 27 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA022453 | NIH | None | None |
| WSU-D-696-87 | None | None | None |
| NCI-V93-0345 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |